Top

Published in:

Open Access 01-12-2023 | Digital Health | Research

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial

Authors: Shenmeng Xu, Xianming Tan, Chunxuan Ma, Rebecca S. McElyea, Karl Shieh, Angela M. Stover, Angela Smith, Karyn Stitzenberg, Ethan Basch, Lixin Song

Published in: BMC Cancer | Issue 1/2023

Abstract

Background

Cancer patients with newly created ostomies face complications that reduce quality of life (QOL) and increase morbidity and mortality. This proof-of-concept study examined the feasibility, usability, acceptability, and initial efficacy of an eHealth program titled the “Patient Reported Outcomes-Informed Symptom Management System” (PRISMS) during post-ostomy creation care transition.

Methods

We conducted a 2-arm pilot randomized controlled trial among 23 patients who received surgical treatment with curative intent for bladder and colorectal cancer and their caregivers. After assessing QOL, general symptoms, and caregiver burden at baseline, participants were randomly assigned to PRISMS (n = 16 dyads) or usual care (UC) (n = 7 dyads). After a 60-day intervention period, participants completed a follow-up survey and post-exit interview. We used descriptive statistics and t-tests to analyze the data.

Results

We achieved an 86.21% recruitment rate and a 73.91% retention rate. Among the PRISMS participants who used the system and biometric devices (n = 14, 87.50%), 46.43% used the devices for ≥ 50 days during the study period. Participants reported PRISMS as useful and acceptable. Compared to their UC counterparts, PRISMS patient social well-being scores decreased over time and had an increased trend of physical and emotional well-being; PRISMS caregivers experienced a greater decrease in caregiver burden.

Conclusions

PRISMS recruitment and retention rates were comparable to existing family-based intervention studies. PRISMS is a useful and acceptable multilevel intervention with the potential to improve the health outcomes of cancer patients needing ostomy care and their caregivers during post-surgery care transition. A sufficiently powered RCT is needed to test its effects.

Trial registration

ClinicalTrial.gov ID: NCT04492007. Registration date: 30/07/2020.

Available only for authorised users

American Cancer Society. Cancer Facts & Figures 2021. 2021. https://www.cancer.org/research/cancer-factsstatistics/all-cancer-facts-figures/cancer-facts-figures-2021.html.

United Ostomy Associations of America. What is an Ostomy?. https://www.ostomy.org/what-isan-ostomy/. Accessed 3 Jan 2022.

Liu L, Herrinton LJ, Hornbrook MC, Wendel CS, Grant M, Krouse RS. Early and late complications among long-term colorectal cancer survivors with ostomy or anastomosis. Dis Colon Rectum. 2010;53(2):200–12. https://doi.org/10.1007/DCR.0b013e3181bdc408.CrossRefPubMedPubMedCentral

Stitzenberg KB, Chang Y, Smith AB, Nielsen ME. exploring the burden of inpatient readmissions after major cancer surgery. JCO. 2015;33(5):455–64. https://doi.org/10.1200/JCO.2014.55.5938.CrossRef

Baldwin CM, Grant M, Wendel C, et al. Gender differences in sleep disruption and fatigue on quality of life among persons with ostomies. J Clin Sleep Med. 2009;05(04):335–43. https://doi.org/10.5664/jcsm.27544.CrossRef

Pittman J, Rawl SM, Schmidt CM, et al. Demographic and clinical factors related to ostomy complications and quality of life in veterans with an ostomy. J Wound Ostomy Continence Nurs. 2008;35(5):493–503. https://doi.org/10.1097/01.WON.0000335961.68113.cb.CrossRefPubMed

Chongpison Y, Hornbrook MC, Harris RB, et al. Self-reported depression and perceived financial burden among long-term rectal cancer survivors: depression and perceived financial burden. Psychooncology. 2016;25(11):1350–6. https://doi.org/10.1002/pon.3957.CrossRefPubMed

Sheetz KH, Waits SA, Krell RW, et al. Complication rates of ostomy surgery are high and vary significantly between hospitals. Dis Colon Rectum. 2014;57(5):632–7. https://doi.org/10.1097/DCR.0000000000000038.CrossRefPubMedPubMedCentral

Bell JF, Whitney RL, Reed SC, et al. Systematic review of hospital readmissions among patients with cancer in the United States. Oncol Nurs Forum. 2017;44(2):176–91. https://doi.org/10.1011/17.ONF.176-191.CrossRefPubMed

10.

Kurtz ME, Kurtz JC, Given CW, Given BA. Utilization of services among elderly cancer patients–relationship to age, symptoms, physical functioning, comorbidity, and survival status. Ethn Dis. 2005;15(2 Suppl 2):S17-22.PubMed

11.

Kurtz ME, Kurtz JC, Given CW, Given B. Predictors of use of health care services among elderly lung cancer patients: the first year after diagnosis. Support Care Cancer. 2006;14(3):243–50. https://doi.org/10.1007/s00520-005-0877-5.CrossRefPubMed

12.

Basch E, Jia X, Heller G, et al. Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst. 2009;101(23):1624–32.CrossRefPubMedPubMedCentral

13.

Keller DS, Khorgami Z, Swendseid B, Khan S, Delaney CP. Identifying causes for high readmission rates after stoma reversal. Surg Endosc. 2014;28(4):1263–8. https://doi.org/10.1007/s00464-013-3320-x.CrossRefPubMed

14.

Sun V, Grant M, McMullen CK, et al. Surviving colorectal cancer: long-term, persistent ostomy-specific concerns and adaptations. J Wound Ostomy Continence Nurs. 2013;40(1):61–72. https://doi.org/10.1097/WON.0b013e3182750143.CrossRefPubMedPubMedCentral

15.

Krouse RS, Grant M, McCorkle R, et al. A chronic care ostomy self-management program for cancer survivors. Psychooncology. 2016;25(5):574–81. https://doi.org/10.1002/pon.4078.CrossRefPubMedPubMedCentral

16.

Song L, Idiagbonya E, Su K, Idiagbonya J. Development of a Personalized mHealth Program for Cancer Symptom and Complication Management. Digit Pers Health Med. 2020;270:1255–6. https://doi.org/10.3233/SHTI200389.

17.

Jung A, Song L, Snyder E, et al. Well-being and perceptions of supportive resources among caregivers of patients with bladder cancer. BLC. 2021;7(1):43–52. https://doi.org/10.3233/BLC-200412.CrossRef

18.

McElyea R, Xu S, Idiagbonya E, et al. Usability Testing of the Patient Reported Outcomes-Informed Symptom Management System: a personalized mHealth Program [Conference presentation]. 44th Annual Conference of Southeast Region of the Wound, Ostomy and Continence Nurses Society, Orlando, FL, United States. Aug 26-28. 2021. https://www.serwocn.org/conference/2020-21/posters/index.html.

19.

Lazarus RS. Stress: Appraisal and coping capacities. How to define and research stress, 5-12. 1986.

20.

Lazarus RS, Folkman S. Stress, appraisal, and coping. Springer Pub. Co. 1984.

21.

Fish DR, Mancuso CA, Garcia-Aguilar JE, et al. Readmission after ileostomy creation: retrospective review of a common and significant event. Ann Surg. 2017;265(2):379–87. https://doi.org/10.1097/SLA.0000000000001683.CrossRefPubMed

22.

Basch E, Reeve BB, Mitchell SA, et al. Development of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014;106(9):dju244.CrossRefPubMedPubMedCentral

23.

Davis FD. Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS Q. 1989;13(3):319. https://doi.org/10.2307/249008.CrossRef

24.

Cella DF, Tulsky DS, Gray G, et al. The functional assessment of cancer therapy scale: development and validation of the general measure. JCO. 1993;11(3):570–9. https://doi.org/10.1200/JCO.1993.11.3.570.CrossRef

25.

Song L, Tan X, Bredle J, Bennett AV, Northouse L. Psychometric properties of the FACT-G quality of life scale for family caregivers of cancer patients. Qual Life Res. 2020;29(8):2241–52. https://doi.org/10.1007/s11136-020-02477-7.CrossRefPubMedPubMedCentral

26.

PROMIS Instrumental Support, Pain Intensity Instrument [Internet]. 2015 [cited April 12, 2016]. Available from: https://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis/listof-adult-measures.

27.

PROMIS Instrumental Support, Sleep Disturbance Instrument [Internet]. 2015 [cited April 12, 2016]. Available from: https://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis/listof-adult-measures.

28.

PROMIS Instrumental Support, Anxiety Instrument [Internet]. 2015 [cited April 12, 2016]. Available from: https://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis/listof-adult-measures.

29.

PROMIS Instrumental Support, Depression Instrument [Internet]. 2015 [cited April 12, 2016]. Available from: https://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis/listof-adult-measures.

30.

PROMIS Instrumental Support, Fatigue Instrument [Internet]. 2015 [cited April 12, 2016]. Available from: https://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis/listof-adult-measures.

31.

Bédard M, Molloy DW, Squire L, Dubois S, Lever JA, O’Donnell M. The Zarit Burden interview. Gerontologist. 2001;41(5):652–7. https://doi.org/10.1093/geront/41.5.652.CrossRefPubMed

32.

Linden WJ. Handbook of item response theory: Volume three. 2018.

33.

Song L, Qan’ir Y, Guan T, et al. The challenges of enrollment and retention: a systematic review of psychosocial behavioral interventions for patients with cancer and their family caregivers. J Pain Symptom Manage. 2021;62(3):e279–304.CrossRefPubMedPubMedCentral

34.

Broderick J, Devine T, Langhans E, Lemerise AJ, Lier S, Harris L. Designing Health Literate Mobile Apps. NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC. 2014. https://doi.org/10.31478/201401a.

35.

Zapata BC, Fernández-Alemán JL, Idri A, Toval A. Empirical studies on usability of mhealth apps: a systematic literature review. J Med Syst. 2015;39(2):1. https://doi.org/10.1007/s10916-014-0182-2.CrossRefPubMed

Title: An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial
Authors: Shenmeng Xu
Xianming Tan
Chunxuan Ma
Rebecca S. McElyea
Karl Shieh
Angela M. Stover
Angela Smith
Karyn Stitzenberg
Ethan Basch
Lixin Song
Publication date: 01-12-2023
Publisher: BioMed Central
Keyword: Digital Health
Published in: BMC Cancer / Issue 1/2023
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-023-10919-x

ERS Congress 2024

Springer Medicine

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial

Abstract

Background

Methods

Results

Conclusions

Trial registration

ERS Congress 2024

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2023

DNMT3A low-expression is correlated to poor prognosis in childhood B-ALL and confers resistance to daunorubicin on leukemic cells

Integrated pancancer analysis reveals the oncogene characteristics and prognostic value of DIP2B in breast cancer

Prior treatment with oxaliplatin-containing regimens and higher total bilirubin levels are risk factors for neutropenia and febrile neutropenia in patients with gastric or esophagogastric junction cancer receiving weekly paclitaxel and ramucirumab therapy: a single center retrospective study

Elevated LILRB1 expression predicts poor prognosis and is associated with tumor immune infiltration in patients with glioma

Salidroside regulates tumor microenvironment of non-small cell lung cancer via Hsp70/Stub1/Foxp3 pathway in Tregs

Peripheral PD-1 and Tim-3 percentages are associated with primary sites and pathological types of peritoneal neoplasms